Kornimate/medical-research-clean huggingface dataset:
feasibility of use of the path bcpap and oxygen blenders device with neonates in uganda

Conditions: Respiratory Distress Syndrome; Infant, Premature

Summary: in this mixed methods study, the investigators assessed feasibility of use of the path bcpap kit on neonatal patients as well as the usability and acceptability of the device by healthcare workers.the study took place in a rural ugandan special care nursery with experience in bcpap. neonates with respiratory failure were consented and treated with the path bcpap kit and blenders. the investigators conducted prospective data collection of the device use through observation as well as collected qualitative data via interviews with nurses, which were analyzed using a rapid qualitative analytical method.

preterm birth is responsible for 1/3 of deaths under age five- the majority which occur in resource-constrained settings. many of these deaths are due to respiratory failure which can be treated with bubble continuous positive airway pressure (bcpap). commercialized bcpap devices are expensive, leading resource-constrained settings to make and use improvised devices. these improvised devices have not been tested for performance and run on 100% oxygen. who guidelines strongly advise against the use of 100% oxygen-particularly with preterm newborns where it can cause blindness, lung and brain injury. to address this need, path has developed a low-cost bcpap kit which includes oxygen blenders that do not require electricity nor a source of pressurized air to blend oxygen with air. the objectives of this early feasibility study are to: 1. assess the operational feasibility of using the path bcpap kit including, when appropriate, in-line oxygen blending on neonatal patients and 2. assess the usability and acceptability of the path bcpap kit with oxygen blenders by healthcare workers. newborns will be treated with the path bcpap kit and a subset of these will also be treated with the path blender as needed to provide blended oxygen. results from this study will be used to identify appropriate modification to the use procedures and/or the device as needed. once testing is completed and product revision finalized, the path kit and blenders will allow resource-constrained settings to provide rigorously tested bcpap therapy and blended oxygen to patients with reduced risk of morbidity from oxygen toxicity.

Eligibility criteria:
inclusion criteria: * newborns \<44 weeks post menstrual age with respiratory failure requiring treatment with bcpap therapy during the period of study * parent or legal guardian consented to participation in the study within 24 hours of bcpap initiation. exclusion criteria: \* no parental nor legal guardian consent for participation in the study.
accuracy testing of validated and non-validated home bp devices sold on the online market.

Conditions: Hypertension

Summary: this study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake bp from ambulatory blood pressure monitoring.


Eligibility criteria:
inclusion criteria: * adults aged \> 18 years scheduled to undergo an abpm exclusion criteria: * upper arm size outside of cuff range of selected devices (\ 42 cm) * night shift workers * permanent atrial fibrillation * known severe aortic stenosis * contraindication to measure bp on the non-dominant arm * ongoing pregnancy * inability or unwillingness to provide consent

Keywords: hypertension blood pressure measurement blood pressure blood pressure device validation
upgraded smart cloth home care system for persons with dementia

Conditions: Dementia; Family

Summary: the purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver app, and to examine its effect on a randomized controlled trial.

the purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver app, and to examine its effect on a randomized controlled trial. this 3-year study will spend the first 6 months to developed the upgraded smart-clothes home care model, and the later 2 and a half years on the clinical trial and follow-ups. in addition to the original function of abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks, this upgraded version will include monitoring for medication, abnormal life pattern, quality of hired help. the warning signals, along with weekly summary and related information will be sent to the family caregiver interactive app after the assessment of the home care nurses to provide guidance for family care. during the first 6 months, the upgraded smart-clothes home care model will be developed according to qualitative and quantitative data of the prior study and expert reviews. for the clinical trial in later 2 1/2 years, a total of 60 participant families will be randomly assigned to experimental (n=30) and control (n=30) group, with experimental group receiving the upgraded smart-clothes home care for 6 months and control group received routine care with 6 month follow-ups. outcomes including caregiver preparedness, balance between competing needs, health related quality of life and depressive symptoms, and fall, time up \& go, activities of daily living (adls), instrumental adls, cognitive function and quality of life of the patient will be followed every 2 month for 6 months. intention-to-treat and hierarchical linear models will be used to analyze the results.

Eligibility criteria:
inclusion criteria: * diagnosed as having dementia * can walk independently or with help * able to communicate * living in northern taiwan. * family caregiver age 20 or older * taking primary responsibility in providing family care. exclusion criteria: * with terminal illness * with severe diseases that can not be controlled.

Keywords: dementia family caregiver smart care home nursing
rehabilitation of type 2 diabetes patients.

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to investigate the effect of a new rehabilitation program of type 2 diabetes patients in a primary care center versus standard care in the outpatient hospital clinic.

type 2 diabetes is major and growing health care problem and is associated with premature mortality and increased morbidity. at the time of diagnosis half of the patients have cardiovascular, renal, ophthalmic or neurological disease. a recent danish intervention study found a marked reduction in cardiovascular events and microvascular complications in a group of patients with type 2 diabetes and microalbuminuria using an intensive multifactorial pharmacologic intervention and lifestyle intervention (3). the achieved changes in lifestyle seems however to vanish after a short period. lack of information, unawareness of the seriousness of the disease and lack of supervised training and insufficient follow-up may be of importance of the long-term outcome in these patients. a total number of 180 patients with type 2 diabetes, will be randomized to the intervention group or to standard care. this study tests an intensive intervention of lifestyle by a newly developed program of rehabilitation compared with routine standards in a randomized controlled design. provided that a significant positive outcome is found, the non-pharmacologic treatment of type 2 diabetes could be optimized and inpatient hospitalization due to complications could be avoided.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus * hgba1c between 6,8 - 10,0% * with or without one or more micro- and macrovascular or neurological complications. exclusion criteria: * hgba1c \ 10,0 % * patients who have attended lifestyle intervention in the past year * patients who is planned to start treatment with insulin during intervention period * lack of motivation * patients with severe heart-, liver or kidney disease or incurable cancer

Keywords: type 2 diabetes, rehabilitation, quality of life, glycaemic control, lifestyle intervention, patient education, physical training, group visits, reminders
efficacy and safety of leningrado association in the treatment of hypertension

Conditions: Arterial Hypertension

Summary: the purpose of this study is to evaluate the efficacy and safety of leningrado association on the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * participants aged 18 years or more; * participants diagnosed with hypertension (mild to moderate), mild to moderate cardiovascular risk, not controlled by monotherapy and/ or lifestyle modification; exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * bp ≥ 180/110 mmhg; * participants with bmi (body mass index) ≥ 40 kg/m2; * previous diagnosis of secondary hypertension; * history of taget organ damage; * history of cardiovascular, hepatic and renal disease; * history of gout, diabetes mellitus and hypokalemia; * current medical history of cancer; * current smoking; * history of alcohol abuse or drug use; * pregnancy or risk of pregnancy and lactating patients; * known allergy or hypersensitivity to the medicines components used during the clinical trial; * participation in clinical trial in the year prior to this study.

Keywords: hypertension
pharmacokinetic and efficacy profile intranasal scopolamine spray

Conditions: Motion Sickness

Summary: part 1, the pharmacokinetic (pk) phase, will expand upon the pilot study conducted at naval medical research laboratory (namrl) and has the goal of determining bioavailability and time to cmax in a larger representative sample. part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.

part 1: the pharmacokinetic (pk) phase objective: to determine the bioavailability and amount of scopolamine absorbed after administration of 0.2 mg intranasal scopolamine at regular intervals across 8 hours post- dose. hypothesis: detectable levels of intranasal scopolamine (inscop) will be present in subject plasma within 15 minutes post-dose; mean time to cmax (maximum plasma concentration) will be less than 1.5 hr. part 2: the efficacy phase objective: to determine the effectiveness, cognitive performance effects, and medication side-effect profile of 0.2 mg intranasal scopolamine spray as a motion sickness (ms) countermeasure. hypothesis: the primary hypothesis is that the inscop spray will be more efficacious against ms than placebo, without statistically significant cognitive performance side-effects. specifically, participants will tolerate significantly more provocative head tilts in the inscop condition than in the placebo condition.

Eligibility criteria:
inclusion criteria: * males and females, 18 to 59 years old, inclusive, in good general health as determined by physical examination and without clinically significant laboratory profiles * normal weight for body size, based on physical readiness test body composition assessment (pprtbca) table * willing and able to comply with study requirements and restrictions; and read and sign the informed consent. exclusion criteria: * known and/or documented drug allergies, especially to scopolamine * use of an investigational drug within 30 days of starting the study * smoking or use of tobacco products, including "chew" or "snuff", within six months * blood donation or significant blood loss within 30 days of starting the study * significant gastrointestinal disorder, asthma, or seizure disorders * history of narrow-angle glaucoma * history of urinary retention problems * history of alcohol or other drug abuse * pregnancy or suspected pregnancy, or lactation * hematocrit values less than 41% for males and 37% for females * recent nasal, nasal sinus or nasal mucosa surgery * use of prescription, over-the-counter, or herbal medication in past 7 days

Keywords: scopolamine motion sickness
comparison of posterior continuous curvilinear capsulorhexis with or without anterior vitrectomy

Conditions: Congenital Cataract

Summary: selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. this prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (pccc) with or without anterior vitrectomy (a-vit) in treating congenital cataracts.

due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. the major concerned postoperative problem is the after-cataract formation. as a result, pccc with a-vit is usually performed to prevent the formation of secondary cataracts. however. debate over the indication and surgical procedure still persists since a-vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. thus, it is necessary to evaluate the safety and effectiveness of pccc without a-vit in congenital cataract surgery. in this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. patients receive cataract surgery on both eyes on the same day. for each patient, one eye is randomly assigned to undergo pccc+a-vit procedure, while the fellow eye is undergoing pccc procedure without a-vit. pccc+a-vit procedure includes anterior continuous curvilinear capsulorhexis (accc), irrigation/aspiration (i/a), pccc, and a-vit. primary intraocular lens implantation (iol) is performed in children older than age of two. investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure between two groups.

Eligibility criteria:
inclusion criteria: * children with bilateral congenital cataracts without other ocular abnormalities * gestational age at birth \>37 weeks * no more than 18 years old * pupils could dilate normally pre-operation * have signed a consent form * can be followed exclusion criteria: * intraocular pressure \>21 mmhg * history of ocular trauma and intraocular surgery

Keywords: congenital cataract surgery anterior vitrectomy postoperative complications
the titan versus everolimus intracoronary stent (xience v) in diabetic patients

Conditions: Diabetes Mellitus; Percutaneous Coronary Intervention

Summary: even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc...), which make prolonged use of clopidogrel unsuitable. a considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent. the titanic-xv trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (titan2®, hexacath, paris, france) implantation as compared with everolimus drug eluting stent (xience-v®, abbott vascular, santa clara, california, usa) in diabetic patients undergoing percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * age over 18 years * diabetes mellitus according to the world health organization report * percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft. * informed consent "signed" exclusion criteria: * inclusion in another clinical research protocol * pregnancy * stemi within 48 hours * unprotected left main disease * restenotic lesions * stent diameter \ 3,5 mm * stent length more than 28 mm in \< 3 mm vessels * chronic total occlusions * allergy to aspirin, clopidogrel, heparin or abciximab * active bleeding or a significant increase in bleeding risk * significant renal insufficiency defined as creatinine \> 2 mg/dl * severely depressed lv function (ef≤35%) * cardiogenic shock * ischemic stroke within the last 6 months * contraindication for des * disease with life expectancy \< 12 months

Keywords: drug eluting stent bioactive bare metal stent
variability of the autonomic nervous system (ans) during cluster headache (ch).

Conditions: Cluster Headache

Summary: cluster headache (ch) is associated with ipsilateral vegetative signs, related to parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. the precise mechanism of cluster headache (ch) is still unknown. the question is whether these dysautonomic disorders are simply secondary to the cluster headache (ch) process or whether they are the triggering factor.

this study cares about the evolution of the autonomic nervous system (ans) in cluster headache (ch) seizures. patients will be offered holter ecg to study the temporal relationships between changes in autonomic nervous system (ans) activity during headache (ch) seizures and changes in autonomic nervous system (ans) activity before and after seizure treatment, using heart rate variability measurement. the hypothesis is that there would be an initial temporary sympathetic activation, followed quickly by parasympathetic hyperactivation and a return to a state of equilibrium.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age * affiliated or entitled to a social security scheme * resident in the territories of the hospital grouping of loire territory (located less than 50 km away) * whose diagnosis of episodic or chronic cluster headache (ch) has been confirmed according to international classification of headache disorders (ichd)- 3 criteria * with a regular sinus rhythm and heart rate exclusion criteria: * conditions contraindicating the use of injectable sumatriptan * conditions likely to affect the autonomic nervous system (ans): dysautonomic sensory neuropathies, sleep apnea syndrome, etc. * cognitive or language disorders that may interfere with pain assessment and seizure follow-up. * patients taking treatments that may modify the autonomic nervous system (ans): catecholamine (adrenaline, noradrenaline, dopamine), b-stimulants (isoprenaline, dobutamine, dopexamine, salbutamol, terbutaline, fenoterol, orciprenaline, clenbuterol, salmeterol, formoterol), b-blockers, alpha-stimulants (midodrine, alpha-methyl-dopa, clonidine, rilmenidine, moxonidine), alpha-blockers (phentolamine, prazosin, urapidil), amphetamine, tyramine, ephedrine, selegiline, cocaine, imipramine. * impossibility to submit to the medical follow-up of the program for geographical, social or psychological reasons. * patient deprived of liberty or under guardianship. * patient with preventive background treatment of cluster headache (ch).

Keywords: cluster headache autonomic nervous system seizure holter electrocardiogram (lf/hf) ratio daytime seizure night seizure
evaluation of the efficacy of dissociation-focused cognitive behavior therapy: a multicenter randomized controlled trial

Conditions: Dissociative Disorder

Summary: dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. to date, no treatment has proven effective for this type of problem. exploratory studies (without control group) have been carried out. among these studies, dissociation-focused cognitive behavioral therapy (df-cbt) seems promising. df-cbt is based on a solid empirical model that has received numerous scientific evidence.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * membership of a social security scheme * participant's express consent * have at least one diagnosis of dissociative disorder among the following: depersonalization/derealization disorder, dissociative identity disorder, unspecified dissociative disorder. * be able to carry out psychotherapy sessions. * if taking psychiatric medication, treatment must have been stable for at least 30 days. exclusion criteria: * present one of the following current diagnoses: substance use disorder (excluding tobacco), neurodevelopmental disorder, anorexia nervosa, severe depressive disorder, schizophrenia spectrum disorder, bipolar disorder, personality disorder other than borderline personality disorder. * present cognitive deficits. * be engaged in psychotherapeutic work. * be undergoing benzodiazepine treatment.
strength and muscle related outcomes for nutrition and lung function in cf

Conditions: Cystic Fibrosis

Summary: the goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy x-ray absorptiometry (dxa) output, which is considered the current clinical gold-standard tool to measure body composition. the result of this study will provide detailed data regarding the nutrition and body composition within this cystic fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with cf across the spectrum of pulmonary function.


Eligibility criteria:
inclusion criteria: * cohort 1: patients are eligible if their percentage of predicated forced expiratory volume in1 second (fev1) is 60% or lower at screening. * cohort 2: patients are eligible if their percentage of predicted forced expiratory volume in 1 second (fev1) is 60% or greater at screening. * both cohorts match by age, gender, race and cftr genotype severity. exclusion criteria: * no prior solid organ transplantation * no initiation of an investigation drug within 28 days prior to and including visit 1 * no initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, cayston, cftr modulator) within 28 days prior to and including visit 1. * no acute use of antibiotics (oral, inhaled or iv) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including visit 1. * for the bia sub-study - individuals with an implanted pacemaker will be excluded. * no initiation of a drug for weight loss (such as a glp-1 receptor agonist) or bariatric surgery within 6-months prior to and including the baseline visit. * patients with continued rapid change or extreme gi symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.